Download summary of the product characteristics

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TrioBe tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains: folic acid 0.8 mg, cyanocobalamin 0.5 mg, pyridoxine hydrochloride 3.0 mg.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Pale yellow tablet with small dots, round, convex, marked R109, with a diameter of 10 mm.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Prevention of symptomatic vitamin B6, vitamin B12 and folic acid deficiency due to
insufficient food intake or malabsorption, primarily in the elderly.
4.2
Posology and method of administration
For oral use. 1 tablet daily with water.
4.3
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Secondary prevention of NTD (neural tube defects).
4.4
Special warnings and precautions for use
TrioBe is not intended for the treatment of symptomatic deficiencies of the vitamins included.
Especially, it should be noted that the effective treatment of manifest megaloblastic anaemia
and pernicious anaemia may need parenteral administration of vitamin B12 at the start of
therapy. TrioBe should not be used in patients who have been subject to major resection of the
small intestine.
4.5
Interaction with other medicinal products and other forms of interaction
Folic acid may increase the metabolism of some antiepileptics, such as phenobarbital and
phenytoin. It may also interfere with the action of folic acid antagonists such as methotrexate,
trimethoprim and pyrimethamin.
4.6
Fertility, pregnancy and lactation
No known risks.
4.7
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8
Undesirable effects
Adverse reactions frequencies are defined as: rare (>1/10,000, <1/1,000).
Skin and subcutaneous tissue disorders
Rare: acne like reactions, allergic reactions (urticaria, pruritus, erythema).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national
reporting system [To be completed nationally]
.
4.9
Overdose
Folic acid has low toxicity. No side effects have been noted in adults who have either taken
400 mg/day for 5 months or 10 mg/day for 5 years.
At chronic high dose treatment with pyridoxine, some individuals have developed peripheral
neuropathies. The dose level of vitamin B6 in TrioBe constitute no risk of overdose.
Cyanocobalamin has low toxicity. No symptoms are to be expected even after high doses.
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PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: ATC-code: A11E Vitamin B-complex
The amounts of folic acid, vitamin B6 and vitamin B12 in TrioBe have been chosen to provide
protection against symptomatic deficiencies especially in elderly people who frequently have
malabsorption of folic acid and vitamin B12.
Folic acid and vitamin B12 are necessary for certain transmethylation processes, e.g. in the
synthesis of DNA and RNA. Folic acid deficiency leads to megaloblastic anaemia of the same
type as in vitamin B12 deficiency.
One intervention trial has shown that treatment with TrioBe reduces elevated plasma levels of
homocysteine. Homocysteine is a metabolite formed during the metabolism of the essential
amino acid methionine. The turnover of homocysteine is influenced by folic acid, vitamin B6
and vitamin B12 and the plasma level of homocysteine rises markedly in folic acid and vitamin
B12 deficiency.
An age-related increase of homocysteine levels has been observed. There is increasing
evidence that elevated homocysteine levels are associated with an increased risk for e.g.
coronary heart disease.
The recommended intake of vitamin B6 for women is 1.2 mg and for men 1.4 mg per day.
The recommended intake of vitamin B12 for women and men is 3 microg per day.
The recommended intake of folic acid is 300 microg per day for both women and men.
5.2
Pharmacokinetic properties
Perorally administered vitamin B12 is passively absorbed in the small intestine in the absence
of intrinsic factor. The degree of absorption is approx. 1% independent of the dose, and
therefore 1 tablet of TrioBe daily well covers the daily need in all kinds of vitamin B12
deficiency. The transcobalamines in serum are regarded to be saturated at 750-1500 pmol/l of
vitamin B12. Not protein bound cyanocobalamin in amounts above this, are very quickly
excreted through glomerular filtration.
Folic acid is rapidly absorbed mainly from the proximal part of the small intestine. The
predominant form of circulatory folic acid is 5-methyltetrahydrofolate. The principal storage
site is the liver, it is also actively concentrated in the cerebrospinal fluid. Administration of
larger doses of folic acid leads to proportionately more of the vitamin being excreted in the
urine.
All forms of vitamin B6 are freely absorbed by passive diffusion in the jejunum and ileum.
The small intestine is able to absorb amounts of vitamin B6 greatly in excess of physiological
need. The predominant form of circulatory vitamin B6 is pyridoxal phosphate and
pyridoxamine phosphate. The storage and metabolism of vitamin B6 is mainly in the liver
where it is oxidized to form pyridoxic acid, the major excretory product of vitamin B6.
5.3
Preclinical safety data
There are no preclinical data of relevance to the safety evaluation beside those already referred
to in the summary of product characteristics.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Calcium hydrogen phosphate dihydrate
Microcrystalline cellulose
Sodium starch glycollate
Magnesium stearate
Colloidal anhydrous silica
6.2
Incompatibilities
Not applicable.
6.3
Shelf-life
3 years.
6.4
Special precautions for storage
Do not store above 30o C. Store in the original container in order to protect from moisture.
6.5
Nature and contents of container
30, 60, 100 and 250 tablets in white plastic bottle of HDPE (polyethylene).
Some packages are especially adjusted having an accessibility cap for people with reduced
function of the hands. Not all pack sizes may be marketed.
6.6
Special precautions for disposal and other handling
No special requirements.
7
MARKETING AUTHORISATION HOLDER
Recip AB, Box 906, 170 09 Solna, Sweden
8
MARKETING AUTHORISATION NUMBER(S)
13668
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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 2 July 1999
Date of latest renewal: 2 July 2009
10
DATE OF REVISION OF THE TEXT
21 January 2016